Ustekinumab

Generic name
Ustekinumab
Brand name
ATC Code
L04AC05
Compare …

Ustekinumab

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Serum concentrations of ustekinumab in children with psoriasis (aged 6 to 17 years) and in children with Crohn's disease (weighing at least 40 kg) treated with the recommended dose based on body weight were generally comparable to those in adult patients.
Serum concentrations of ustekinumab in pediatric psoriasis patients aged 12 to 17 years (CADMUS) treated with half the recommended dose based on body weight were generally lower than those in adults.

Kinetic data in adults:

  Subcutaneous Intravenuus
Tmax ca. 8½ day 1 hour
Vd 0,06–0,08 l/kg, greater for a body weight > 100 kg 57-83 ml/kg
T1/2 circa 3 weken (15–32 days), shorter for a body weight > 100 kg  
Cl   1,99 tot 2,34 ml/day/kg

 

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Moderate to severe plaque psoriasis, with insufficient response to or intolerance of other therapy
  • Subcutaneous
    • ≥ 6 years and < 60 kg
      • 0.75 mg/kg/dose on weeks 0, 4 and thereafter every 12 weeks.
    • ≥ 6 years and 60 up to 100 kg
      • 45 mg/dose on weeks 0, 4 and thereafter every 12 weeks.
    • ≥ 6 years and ≥ 100 kg
      • 90 mg/dose on weeks 0, 4 and thereafter every 12 weeks.
Crohn’s disease
  • Subcutaneous
    • ≥ 40 kg
      • Initial dose: ATTENTION: STARTING DOSE INTRAVENOUSLY: 6 mg/kg/dose, once only.
      • Maintenance dose: SUBCUTANEOUS (8 weeks after IV injection): 90 mg/dose every 8-12 weeks.

      • Discontinue treatment if the patient does not benefit from the treatment after 16 weeks.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The side effect profile in children is generally similar to that in adults.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

IMMUNOSUPPRESSANTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Selective immunosuppressants
L04AA24
L04AA32
L04AA13
L04AA02
L04AA06
L04AA31
L04AA04
L04AA44
Other immunosuppressants
L04AX01
L04AX03
Tumor necrosis factor alpha (TNF-alpha) inhibitors
L04AB04
L04AB01
L04AB06
L04AB02
Interleukin inhibitors
L04AC03
L04AC02
L04AC08
L04AC13
L04AC19
L04AC10
L04AC22
L04AC07
Calcineurin inhibitors
L04AD01
L04AD02
Sphingosine-1-phosphate (S1P) receptor modulators
L04AE01
Janus-associated kinase (JAK) inhibitors
L04AF02
L04AF02
L04AF08
L04AF01
Monoclonal antibodies
L04AG04
Mammalian target of rapamycin (mTOR) kinase inhibitors
L04AH02
L04AH01
Complement inhibitors
L04AJ01
L04AJ02
Dihydroorotate dehydrogenase (DHODH) inhibitors
L04AK02

References

  1. Janssen-Cilag International NV, SmPC Stelara( EU/1/08/494/001) 18-11-2021, www.ema.europa.eu
  2. Janssen-Cilag International NV, SmPC Stelara( EU/1/08/494/001) Rev 51; 14-04-2025, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose